Please see my response to your questions below:
1. In the most recent feedback we received from FDA, we were told that both inspections are not scheduled until the PMA converts into a Traditional PMA. Having said that, it is possible that different centers use a different approach to this. My suggestion would be to contact them regarding this at least 90 days before submitting the clinical module.
2. I think you could totally request that, as long as it gives them enough time meet their timelines.
Best of luck!
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Maham Ansari MS, RAC
Director, IVD Regulatory & Quality Consulting
Precision for Medicine
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Original Message:
Sent: 02-Sep-2021 12:41
From: Anonymous Member
Subject: Pre-Approval Inspection and B.I.M.O. Audits: Modular PMA
This message was posted by a user wishing to remain anonymous
Dear Maham,
This is just amazing information. Thank you for your input.
- We are working on a mock BIMO audit and the consultant (who does many of these) said FDA is doing BIMO audits just before the clinical module is submitted. You have heard or had similar experience?
- If FDA does BIMO and PAI after the clinical module is submitted, can we ask them to space it out so we get time to prepare as most of the resources will be the same.
Thanks!
Original Message:
Sent: 02-Sep-2021 09:07
From: Maham Ansari
Subject: Pre-Approval Inspection and B.I.M.O. Audits: Modular PMA
Hello Anon,
For modular PMA's, you are generally supposed to be following FDA's modular guidance from 2003, but FDA recently confirmed that the guidance is very outdated and they have had some re-organization since. For both Pre-approval inspection and B.I.M.O audit, FDA would only schedule these audits once your last (clinical) module has been submitted and closed after the 90-day clock, i.e. at which point your modular PMA converts to a traditional PMA and the 180-day clock kicks off. You can surely notify the FDA at least 90 days before you intend to submit your clinical module (per the modular guidance) but they would typically only come in to audit you once your modular PMA has been turned to a traditional PMA (during the 180-day clock).
To prepare for the PAI, you should follow 21CFR820 and an FDA guidance I have attached here. You should also follow ISO 13485: 2016 is FDA is starting to lean toward that model. I have also attached the modular PMA guidance from 2003.
Hope this helps.
Regards,
------------------------------
Maham Ansari MS, RAC
Director, IVD Regulatory & Quality Consulting
Precision for Medicine
Original Message:
Sent: 31-Aug-2021 16:25
From: Anonymous Member
Subject: Pre-Approval Inspection and B.I.M.O. Audits: Modular PMA
This message was posted by a user wishing to remain anonymous
My company has submitted a 2 modules of an original PMA (our first PMA) to FDA. The last 2 modules are manufacturing and clinical.
I wanted to know when should we expect FDA to show-up for the pre-approval inspection and B.I.M.O. audit i.e.
- Pre-approval inspection:
- Will FDA schedule an audit before closing the Manufacturing Module (M3) or they would come after the manufacturing module is closed?
- Is there any specific guidance or check list which we can refer to for preparing for this audit?
- B.I.M.O. audit:
- Will FDA come for a BIMO audit 90 days after we submit our last (clinical) module?
Any insights will be helpful. If there are specific guidance's or regulations which support this, it will help me to talk to my team accordingly.
Thanks!